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Data collection and management designed for MedTech clinical trials.

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Posts by Michelle Lott

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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About the Author

Michelle Lott is the Principal and Founder of Lean RAQA, a regulatory and quality consultancy for medical device companies. Michelle currently serves a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP); reviewing feasibility and reasonableness, recommending proposed good manufacturing practice regulations in manufacturing, packing, storing, and installing devices. Michelle achieved a Regulatory Affairs Professionals Society Executive Leadership Certification from Northwestern Kellogg School of Management and a BS in Chemistry from Troy State University. Interesting fact: Michelle formerly served as an expert witness in forensic toxicology at the Mississippi Crime Laboratory.

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Establishing a QMS

Should you Swipe Right or Left on your Notified Body?

Michelle Lott
July 7, 2019
How long have you been dating your Notified Body – “NB” for short? Is your eye beginning to wander? It should wander if your NB won’t be able to support your business once... Read More

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